BMS Receives New Approval for Opdivo

On March 4, 2015, Bristol-Myers Squibb Company announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Opdivo is the first and only PD-1 (programmed death receptor-1) therapy to demonstrate overall survival in previously treated metastatic squamous NSCLC.

Click Here to read the News Release and full Prescribing Information.

Click Here to access the Opdivo Fact Sheet

New Liquid Formulation of KEYTRUDA®

Merck Sharp & Dohme Corp. (Merck), a subsidiary of Merck & Co., Inc., is pleased to announce the availability of a liquid formulation of KEYTRUDA. Merck expects to make this product available on or after February 16, 2015. Check with your authorized distributor for details. This 100-mg liquid vial will replace the 50-mg lyophilized formulation, which was launched as a transition image until the liquid formulation was available. The price per mg has not changed with the introduction of this image.

Click Here to read the notice with important NDC and coding information.

Click Here for the Prescribing Information.

Click Here for the Medication Guide.

 

Neulasta® Delivery Kit Now Available

A new administration option for Neulasta® is now available: the Neulasta® Delivery Kit.  

The Neulasta® Delivery Kit (NDC: 55513-192-01) requires administration by a healthcare provider and is available at the same WAC (wholesale acquisition cost) as the currently available Neulasta® prefilled syringe (NDC:  55513-190-01).

Neulasta® is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

Neulasta® is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. 

Please click here for the Neulasta® Prescribing Information. 

Please click here for the On-body Injector for Neulasta® Instructions for Use. 

 

New FDA Approval for Lilly's CYRAMZA

On December 12, 2014, the US Food and Drug Administration (FDA) approved a new indication for CYRAMZA® (ramucirumab). CYRAMZA, in combination with docetaxel, is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with disease progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving CYRAMZA. This is the third FDA-approval for CYRAMZA.

CYRAMZA is also indicated as a single agent, or in combination with paclitaxel, for the treatment of patients with advanced or metastatic gastric or gastroesophageal junction adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy.

For more information, please visit www.CYRAMZAhcp.com

Please click here for full Prescribing Information including Boxed Warning for hemorrhage.

 

Important Coding, Purchasing and Reimbursement Changes for Xofigo

Bayer has released information on new coding, purchasing and reimbursement changes for their drug Xofigo effective January 1, 2015.

Please Click Here to read the detailed information from Bayer.  

 

Bristol-Myers Squibb Announces FDA Approval for Opdivo

On December 22, 2014 the US Food and Drug Administration (FDA) granted accelerated approval to nivolumab (Opdivo, Bristol-Myers Squibb) for the treatment of advanced melanoma.

The indication is for patients with unresectable or metastatic melanoma and disease progression after treatment with ipilimumab (Yervoy) and, for patients whose tumors are BRAF V600 mutation positive, a BRAF inhibitor.

Click Here for the Bristol-Myers Squibb Press Release. 

Click Here for a Fact Sheet on Opdivo.

Jakafi Receives New Indication

The U.S. Food and Drug Administration today approved a new use for Jakafi (ruxolitinib) to treat patients with polycythemia vera, a chronic type of bone marrow disease. Jakafi is the first drug approved by the FDA for this condition.

Click Here for the Jakafi PI

 

XGEVA Receives New FDA Approval

On December 5, 2014 the Food and Drug Administration (FDA) approved a new indication for XGEVA® (denosumab) as follows:

XGEVA® is indicated for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Please click here to link to the updated XGEVA® Prescribing Information (PI).

Important Safety Information

XGEVA® is contraindicated in patients with pre-existing hypocalcemia and clinically significant hypersensitivity to XGEVA®.  XGEVA® can cause severe symptomatic hypocalcemia, and fatal cases have been reported.  Osteonecrosis of the jaw and atypical fracture have been reported.  XGEVA® can cause fetal harm.  Females of reproductive potential should use highly effective contraception during therapy, and for at least 5 months after the last dose of XGEVA®.